NCT04187352

A Study of CS1001 in Subjects With Esophageal Squamous Cell Carcinoma

A Multi-Center, Double-Blind, Randomized, Phase III Study to Investigate the Efficacy and Safety of CS1001 in Combination With Fluorouracil and Cisplatin (FP) Compared to Placebo in Combination With FP as First-Line Therapy in Subjects With Unresectable Locally Advanced, Recurrent or Metastatic Esophageal Squamous Cell Carcinoma (ESCC)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 540 (actual)
• Sponsor: CStone Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Phase III Study to Investigate the Efficacy and Safety of CS1001 or Placebo in Combination with FP as First-Line Therapy in Subjects with Unresectable Locally Advanced, Recurrent or Metastatic Esophageal Squamous Cell Carcinoma

Conditions

• Unresectable Locally Advanced, Recurrent or Metastatic Esophageal Squamous Cell Carcinoma

Interventions

Type	Name	Description
DRUG	CS1001+ Fluorouracil+Cisplatin	CS1001 1200 mg, intravenous infusion on the first day of each cycle (3 weeks) (Q3W). Fluorouracil: 800 mg/m2/day, continuous intravenous infusion on Day 1 to Day 4 of each cycle Cisplatin: 80 mg/m2, intravenous infusion on the first day of each cycle.
DRUG	Placebo+ Fluorouracil+Cisplatin	Placebo 1200 mg, intravenous infusion on the first day of each cycle (3 weeks) (Q3W). Fluorouracil: 800 mg/m2/day, continuous intravenous infusion on Day 1 to Day 4 of each cycle Cisplatin: 80 mg/m2, intravenous infusion on the first day of each cycle.

Timeline

• Start date: 2019-12-19
• Primary completion: 2022-10-07
• Completion: 2022-10-07
• First posted: 2019-12-05
• Last updated: 2023-11-24

Locations

72 sites across 1 country: China